BASF AS completed a randomized, placebo-controlled clinical trial in the U.S., newly published in Nutrients, evaluating the use of high concentrate omega-3 to correct the nutritional deficiency of omega-3 fatty acid in patients with non-alcoholic fatty liver disease (NAFLD). Several studies have shown that NAFLD patients have lower levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

The study, covering 176 patients, demonstrates that intervention with high concentrate omega-3 for 24 weeks significantly raises the omega-3 index in adults with NAFLD compared to placebo, thereby correcting the patients’ nutritional deficiency. Patients showed reductions of up to 44% in liver fat after placebo correction, providing evidence that clinical management of NAFLD with high concentrate omega-3 has a beneficial outcome on liver fat. This intervention study supports a recently published meta-analysis that concluded omega-3 fatty acids are associated with significant improvements in liver fat and liver function tests with approximately 3 grams of EPA and DHA daily.

BASF launched Hepaxa in February 2018 in the U.S. as the first-to-market, dedicated product for the dietary management of patients with NAFLD. Hepaxa increases the levels of EPA and DHA in patients with NAFLD, which improves the liver´s ability to process fat in the liver. These data support the use of Hepaxa for patients with NAFLD. Together with diet and exercise, Hepaxa offers a viable and dedicated option for managing NAFLD, the company said.

“Science has always been the backbone of all our development work and efforts in the area of liver health, and this study is further evidence that Hepaxa can significantly reduce liver fat content, which is crucial in managing NAFLD,” said Derek Tobin, team leader for innovation, Advanced Health Solutions, BASF.

“We are excited about the growing and solid scientific basis for our product and its beneficial effects in the dietary management of NAFLD. Hepaxa can truly help millions of patients today with what has become a growing chronic disease,” said Christoph Garbotz, head of commercial management Advanced Health Solutions, BASF.

Hepaxa is manufactured using a patented purification technology, which removes persistent organic pollutants and other unwanted lipids, such as cholesterol, that are naturally found in many fish oil-based products. Research has shown that one specific pollutant, PCB 153, is particularly harmful in NAFLD. As the liver function of NAFLD patients is compromised, it is important to limit exposure to unwanted components that are present in many less-refined fish oils. Hepaxa is GRAS (Generally Recognized As Safe) for use as a medical food for the dietary management of NAFLD at intakes of up to 3 grams/day of EPA & DHA for both adults and pediatrics 10 years of age and older.

A poster presentation of the BASF study will be displayed at the “American Association for the study of Liver Diseases (AASLD)” conference in San Francisco, Nov. 9-13.

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